CROSSWALK
IEC 81001-5-1 Cybersecurity Lifecycle Crosswalk
Clause-by-clause breakdown of IEC 81001-5-1 cybersecurity requirements for health software. Maps each requirement to ISO 13485 and ISO 14971.
Cybersecurity
| IEC 81001-5-1 Clause | ISO 13485 Mapping | Requirement | Gaps | Details |
|---|---|---|---|---|
| §4.1.1, 4.1.2 | 4.1 | QMS and Security Responsibilities | 1 | View → |
| §4.1.3 | Identification of Applicability | 1 | View → | |
| §4.1.4 | 6.2 | Security Expertise and Training | 1 | View → |
| §4.1.5 | 7.4 | Third-Party Supplier Security | 1 | View → |
| §4.1.6, 4.1.8 | 4.1, 8.5 | Continuous Improvement and Periodic Review | 1 | View → |
| §4.1.7 | 7.2.3 | Disclosing Security-Related Issues | 1 | View → |
| §4.1.9 | 7.3 | Accompanying Documentation Review | 1 | View → |
| §4.2 | Security Risk Management | 1 | View → | |
| §4.3 | 7.4 | Software Item Classification for Risk Transfer | 1 | View → |
| §5.1.1 | 7.3.2 | Security Life Cycle Activities Planning | 1 | View → |
| §5.1.2 | Development Environment Security | 1 | View → | |
| §5.1.3 | Secure Coding Standards Planning | 1 | View → | |
| §5.2.1 | Health Software Security Requirements | 1 | View → | |
| §5.2.2 | Security Requirements Review | 1 | View → | |
| §5.2.3 | Security Risks for Required Software | 1 | View → | |
| §5.3.1 | Defense-in-Depth Architecture | 1 | View → | |
| §5.3.2 | Secure Design Best Practices | 1 | View → | |
| §5.3.3 | Security Architectural Design Review | 1 | View → | |
| §5.4.1 | Secure Software Design | 1 | View → | |
| §5.4.3 | Secure Health Software Interfaces | 1 | View → | |
| §5.4.4 | Detailed Design Verification for Security | 1 | View → | |
| §5.5.1 | Secure Coding and Implementation Review | 1 | View → | |
| §5.6 | Security in Integration Testing | 1 | View → | |
| §5.7.1 | Security Requirements Testing | 1 | View → | |
| §5.7.2 | Threat Mitigation Testing | 1 | View → | |
| §5.7.3 | Vulnerability Testing | 1 | View → | |
| §5.7.4 | Penetration Testing | 1 | View → | |
| §5.7.5 | Tester Independence | 1 | View → | |
| §5.8.1 | Pre-Release Security Verification | 1 | View → | |
| §5.8.2 | Security Release Documentation | 1 | View → | |
| §5.8.3 | File Integrity and Private Key Controls | 1 | View → | |
| §5.8.7 | Secure Decommissioning Guidelines | 1 | View → | |
| §6.1.1 | Timely Security Update Policy | 1 | View → | |
| §6.2.1 | Monitoring Public Incident Reports | 1 | View → | |
| §6.2.2 | Security Update Verification | 1 | View → | |
| §6.3.1, 6.3.2, 6.3.3 | Security Update Documentation and Delivery | 1 | View → | |
| §7.1.1, 7.1.2 | Risk Management Context and Product Security Context | 1 | View → | |
| §7.2 | Threat and Vulnerability Identification | 1 | View → | |
| §7.3 | Security Risk Estimation and Evaluation | 1 | View → | |
| §7.4 | Controlling Security Risks | 1 | View → | |
| §7.5 | Monitoring Risk Control Effectiveness | 1 | View → | |
| §8 | Software Configuration Management | 1 | View → | |
| §9.2 | Receiving Vulnerability Notifications | 1 | View → | |
| §9.3 | Reviewing Vulnerabilities | 1 | View → | |
| §9.4 | Analysing Vulnerabilities | 1 | View → | |
| §9.5 | Addressing Security-Related Issues | 1 | View → |
Other standards
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